Omeros files OMS 302 at FDA for Intraocular Lens Replacement
Omeros Corporation announced that the company recently submitted a New Drug Application (NDA) to the FDA for approval of OMS 302 for use in patients undergoing Intraocular Lens Replacement (ILR) surgery.
Added to standard irrigation solution used during ILR, OMS302 is Omeros' proprietary PharmacoSurgery product that, across multiple human trials, demonstrated clinically meaningful and statistically significant maintenance of intraoperative mydriasis (pupil dilation), prevention of intraoperative miosis (pupil constriction), and reduction of postoperative ocular pain.
In addition, Omeros plans to submit a Marketing Authorization Application to the European Medicines Agency (EMA) via the EMA's centralized procedure this quarter.
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